Kane Arianne, Parker Michael T
Department of Biology, Georgetown University, Washington, DC, USA.
College of Arts & Sciences, Georgetown University, Washington, DC, USA.
Appl Biosaf. 2024 Jun 20;29(2):85-95. doi: 10.1089/apb.2023.0027. eCollection 2024 Jun.
Synthetic DNA technology is rapidly emerging as a key driver of innovation in the fields of medicine, biotechnology, and more. But it also poses significant risk, particularly in lowering barriers to the production of dangerous pathogens and toxins. At present, oversight of this technology is voluntarily coordinated among synthetic DNA providers and stakeholders, and detailed understanding of security processes, infrastructures, and insights from these providers is imperative to understand how to best mitigate the inherent risks of this technology.
In this study, we aimed to determine the trends, outliers, strengths, and gaps in current DNA provider security practices through a broad survey of the gene synthesis field.
We interviewed synthetic DNA providers and stakeholders about their customer and sequence screening procedures. Respondents were divided into groups based on membership in the International Gene Synthesis Consortium, nationality, whether they were a new or established company, and whether they synthesize de novo DNA or not. We then performed meta-analysis and intergroup analysis to elucidate larger trends and points of variance.
In total, we interviewed 18 companies. We found that synthetic DNA providers and stakeholders tend to operate under a "zero-trust model" for screenings and utilize common governmental and private resources to navigate international import/export policies. Major variabilities were identified in the sensitivity of screening, monitoring and evaluation practices, screening pipelines, and approaches to synthetic oligonucleotide screening. In addition, we identified a significant vulnerability of lacking awareness among providers of formal law enforcement reporting procedures.
Collectively, we observed significant heterogeneity in security practice throughout the field, reflective of the current lack of codified oversight for DNA synthesis. The results presented in this study provide insight into the specifics, strengths, and shortcomings of current DNA provider security practices, and are important considerations for the biosecurity community in ongoing deliberations of if, when, and how to approach oversight of synthetic DNA technology.
合成DNA技术正迅速成为医学、生物技术等领域创新的关键驱动力。但它也带来了重大风险，尤其是降低了生产危险病原体和毒素的门槛。目前，该技术的监管由合成DNA供应商和利益相关者自愿协调，深入了解这些供应商的安全流程、基础设施以及见解，对于理解如何最好地降低该技术的固有风险至关重要。
在本研究中，我们旨在通过对基因合成领域的广泛调查，确定当前DNA供应商安全实践的趋势、异常值、优势和差距。
我们就客户和序列筛选程序采访了合成DNA供应商和利益相关者。受访者根据其在国际基因合成联盟的成员身份、国籍、是新公司还是老牌公司以及是否合成从头DNA进行分组。然后，我们进行了荟萃分析和组间分析，以阐明更大的趋势和差异点。
我们总共采访了18家公司。我们发现，合成DNA供应商和利益相关者在筛选时倾向于采用“零信任模型”，并利用政府和私人的共同资源来应对国际进出口政策。在筛选的敏感性、监测和评估实践、筛选流程以及合成寡核苷酸筛选方法方面发现了主要差异。此外，我们发现供应商对正式执法报告程序缺乏认识是一个重大漏洞。
总体而言，我们观察到整个领域的安全实践存在显著异质性，这反映了目前对DNA合成缺乏编纂的监管。本研究结果深入了解了当前DNA供应商安全实践的具体情况、优势和不足，是生物安全界在讨论是否、何时以及如何对合成DNA技术进行监管时的重要考虑因素。
